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NOT YET RECRUITING
NCT07046286
NA

Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui Da and Medtronic) in Radiofrequency Ablation for Varicose Veins

Sponsor: Chengdu University of Traditional Chinese Medicine

View on ClinicalTrials.gov

Summary

This study aims to systematically compare the clinical efficacy (venous closure rate and symptom relief rate), safety (perioperative and postoperative complications), and cost-effectiveness (direct medical costs) of domestic Xianruida radiofrequency catheter and imported Medtronic catheter in endovenous radiofrequency ablation for varicose veins through a single-center, prospective, non-inferiority randomized controlled trial.

Official title: Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui and Medtronic) in Radiofrequency Ablation for Varicose Veins

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-08-01

Completion Date

2026-10-01

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

PROCEDURE

Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.

1. Surgical Procedures: Standardized radiofrequency ablation (GSV/SSV closure) was carried out in both groups by the same team. Catheter parameters were set as 120°C and 1 cm/min withdrawal speed. The treatment segment of the great saphenous vein was required to be \>1 cm from the skin before anesthesia. For calf varicose veins, treatment was done after great saphenous vein ablation. * Experimental Group: Utilized Xianruida's catheter with advanced features. Surgical and device - related information was recorded. * Control Group: Used Medtronic's catheter. Similar data were recorded as in the experimental group. 2. Postoperative Management: Consistent for both groups. * Compression: Applied elastic bandage + Class II compression stockings. * Medication: Patients took oral anticoagulants and painkillers as needed, with usage details recorded during follow - up.

Locations (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China